NMPA to Regulate the Adjustment of Medical Device Classification

The National Medical Products Administration (NMPA) has recently drafted the Announcement on the Adjustment of Medical Device Classification (Draft for Comment) (the "Draft") for public consultation, with the comment period open until August 16, 2025.

The Draft specifies requirements related to registration and filing following adjustments to the regulatory classification of medical devices, requirements for products adjusted from being regulated as non-medical devices to being regulated as medical devices, and requirements for products no longer regulated as medical devices. According to the Draft, for medical device registration certificates approved prior to the effective date of the classification adjustment as set forth in the relevant documents, the original medical device registration certificates will remain valid until their expiration. From the date of the adjustment to the regulatory category, initial registration applications for medical devices shall be accepted in accordance with the adjusted classification. Furthermore, for medical devices whose regulatory category is adjusted to Class I, the filing of such products as Class I medical devices shall be carried out in accordance with the new category from the date of the adjustment to the regulatory category.



(Source: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20250717112309122.html)

Note: The link to the Chinese official website of the document is for your reference.